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The Effects of Attention Retraining in MS (MSattention)

8. marts 2013 opdateret af: Paivi Hamalainen, Finnish MS Society

The Effects of Attention Retraining on Cognitive Performance, QoL and Perceived Cognitive Impairment in MS - a Single Blind, Randomized, Controlled Study

The purpose of this study is to determine whether neuropsychological rehabilitation focused on attention retraining and teaching compensatory strategies has positive effects on cognitive performance, quality of life (QoL)and perceived cognitive deficits in patients with MS. The hypothesis is that the neuropsychological intervention shows positive effects on cognitive performance, QoL and perceived cognitive deficits.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Background: Cognitive impairments are a typical manifestation of multiple sclerosis (MS). According to previous studies, neuropsychological rehabilitation may improve cognitive performance in MS. However, the quality of previous studies is low and, accordingly, the evidence on the effects of neuropsychological rehabilitation is low to modest.

Objective: To study whether neuropsychological rehabilitation improves cognitive performance, QoL and perceived cognitive deficits in patients with MS.

Methods: Altogether 100 patients with MS are randomised either to intervention or to control group in three different study sites. All the study subjects are assessed with neuropsychological tests as well as self-rating questionnaires evaluating mood, QoL, cognitive deficits, fatigue and impact of the disease at baseline, after three months (immediately after intervention) and after six months. Patients in the intervention group are offered with neuropsychological rehabilitation conducted once a week during thirteen weeks. Patients in the control group do not receive any intervention.

Results: The effects of intervention on cognitive performance, QoL and perceived cognitive impairments are evaluated using appropriate statistical procedures and comparing the differences between the intervention and the control group.

The present status: The baseline assessments have been performed and the intervention will be conducted between September and December, 2011.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

97

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Finland
      • Masku, Finland, 212521
        • Masku Neurological Rehabilitation Centre
      • Seinäjoki, Finland, 60220
        • Seinäjoki Central Hospital
      • Tampere, Finland
        • Tampere University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 58 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with MS are collected from community by informing about the study via information letters send to the members of local MS Associations

Beskrivelse

Inclusion Criteria:

  • clinically definite MS
  • EDSS < 6
  • age 18-58 years
  • subjective cognitive problems and objective decline in attention

Exclusion Criteria:

  • other neurological disease than MS
  • psychiatric diagnosis
  • severe depression
  • secondary progressive or primary progressive course of MS
  • EDSS>=6
  • alcohol or drug abuse
  • relapse during the preceding month of study entry
  • neuropsychological rehabilitation during the study
  • no subjective cognitive cognitive problems and /or no decline in attention
  • overall cognitive impairment (performance in all tests of BRBNT under -1.5 SD compared to norms of healthy controls)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
control
control group: no intervention
neuropsychological rehabilitation
intervention group: neuropsychological rehabilitation (13 times 60 minutes, once per week, during 13 weeks) control group: no intervention
Adfærdsmæssigt: neuropsychological rehabilitation
attention retraining and teaching compensatory strategies as well as offering psychological support to better cope with cognitive impairments (13 times 60 minutes, once per week during 13 weeks)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective cognitive performance
Tidsramme: six months
effects of rehabilitation on objective cognitive performance: SDMT
six months
Subjective cognitive performance
Tidsramme: six months
The effects of rehabilitation on subjective cognitive performance: perceived cognitive deficits (Perceived Deficits Questionnaire, PDQ)
six months
Goal achievement
Tidsramme: six months
Goal achievement: Goal Attainment Scaling (GAS)
six months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of life
Tidsramme: six months
The effects of rehabilitation on QoL: WHOQOL-Bref
six months
Objective cognitive performance
Tidsramme: six months
The effects of rehabilitation on cognitive performances: test of Brief Repeatable Battery of Neuropsychological Tests (BRBNT), Trail Making Test, Stroop test
six months
Mood
Tidsramme: six months
The effects of rehabilitation on mood: Beck Depression Inventory II (BDI II)
six months
Fatigue
Tidsramme: six months
The effects of rehabilitation on self-perceived feeling of fatigue: Fatigue Scale for Motor and Cognitive Fatigue (FSMC)
six months
Subjective cognitive performance
Tidsramme: six months
The effects of rehabilitation on subjective cognitive performance evaluated by the patient him/herself or the significant other: Multiple Sclerosis Neuropsychological Questionnaire (MSNQ-P, MSNQ-I)
six months
The impact of the disease
Tidsramme: six months
The effects of rehabilitation on the impact of the disease: Multiple Sclerosis Impact Scale (MSIS-29)
six months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Finnish MS Society

Samarbejdspartnere

Seinajoki Central Hospital
Social Insurance Institution, Finland
Tampere University Hospital

Efterforskere

  • Studieleder: Päivi I Hämäläinen, adjunct prof, Finnish MS Society / Masku Neurological Rehabilitation Centre
  • Studiestol: Keijo Koivisto, Prof, Seinäjoki Central Hospital
  • Ledende efterforsker: Eija M Rosti-Otajärvi, PhD, Tampere University Hospital
  • Ledende efterforsker: Anu Mäntynen, MA, Seinäjoki Central Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2010

Primær færdiggørelse (Faktiske)

1. april 2012

Studieafslutning (Faktiske)

1. maj 2012

Datoer for studieregistrering

Først indsendt

4. december 2011

Først indsendt, der opfyldte QC-kriterier

12. december 2011

Først opslået (Skøn)

14. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. marts 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. marts 2013

Sidst verificeret

1. marts 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MS1209

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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